Iec 62304 Checklist Xls May 2026

The Ultimate Guide to IEC 62304 Checklist Xls: Ensuring Compliance and Quality in Medical Device Software Development

Sheet 3: Software Risk Management (Clause 4 & 6)

| Clause | Activity | Class A | Class B | Class C | Status | Reference to ISO 14971 | Date | | :--- | :--- | :---: | :---: | :---: | :--- | :--- | :--- | | 4.3(b) | Identify hazardous situations | ✔ | ✔ | ✔ | | Hazard log | | | 6.1 | Risk control measures in software | ✔ | ✔ | ✔ | | Risk control spec | | | 6.2 | Verify risk controls | ✔ | ✔ | ✔ | | Verification report | | | 6.3 | Risk management of software changes | ✔ | ✔ | ✔ | | Change impact analysis | | | 6.4 | Residual risk evaluation | ✔ | ✔ | ✔ | | Residual risk report | | | 6.5 | Risk-benefit analysis (if needed) | ✘ | ✔ | ✔ | | Risk-benefit doc | | Iec 62304 Checklist Xls

How to use this as a paper / document:

  1. Copy the main checklist table into Excel (first row as headers).
  2. Add a "Risk Class" column if your device has multiple software items with different classes.
  3. Use conditional formatting to highlight missing items.
  4. Link to actual documents (e.g., hyperlinks in Excel).
  5. Mark "N/A" for clauses not required for your safety class.

15, 8.1, "Configuration management plan", CM, "Establish CM for software items: baselines, versioning, build control", "CM Plan, baselined repository", "Source, deliverables, and baselines controlled", Not Started, CM Manager, , , High, The Ultimate Guide to IEC 62304 Checklist Xls:

| Req ID | Requirement Description | Safety Class Impact | Design Element (Class/Module) | Code File Name | Unit Test ID | System Test ID | Status | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | REQ-001 | User Login Authentication | High (Class C) | Auth_Module | login.py | UT-Auth-01 | ST-Sec-01 | PASS | | REQ-002 | Display Patient Vitals | Medium (Class B) | UI_Display | vitals.js | N/A | ST-UI-02 | PASS | | REQ-003 | Log Data Export | Low (Class A) | Logger | export.py | N/A | ST-Func-03 | FAIL | Copy the main checklist table into Excel (first

. Slowly, the red and yellow spreadsheet began to glow with successful results. The Final Audit

48, 31.1, "Traceability to system-level risk controls", Risk, "Ensure software contributes to and verifies system-level risk controls", "Trace matrix linking system risk controls to software functions", "All system risk controls implemented or noted as N/A", Not Started, Safety Engineer, , , High,

Tab 7: System Software Testing (Clause 5.6)

This is black-box testing against the Software Requirements Specification (SRS).